Trial Search Results

High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborator: NRG Oncology

Stanford Investigator(s):

Intervention(s):

  • Biological: Cetuximab
  • Drug: Carboplatin
  • Drug: Paclitaxel
  • Radiation: 60 Gy RT
  • Radiation: 74 Gy RT

Phase:

Phase 3

Eligibility


DISEASE CHARACTERISTICS:

   - Histologically or cytologically confirmed newly diagnosed non-small cell lung cancer
   (NSCLC)

      - Stage IIIA or IIIB disease

         - N3 supraclavicular disease or contralateral hilar lymph node involvement
         (i.e. greater than 1.5 cm on short axis or positive on PET scan) not allowed

         - N2 or N3 disease and an undetectable NSCLC primary tumor allowed

      - Unresectable or inoperable disease

   - No distant metastases

   - Pleural effusion allowed provided effusion is minimal and none of the following
   conditions are present:

      - Cytologically positive pleural effusion detectable by CT scan and chest x-ray
      (pleuracentesis required to confirm negative cytology of pleural fluid)

      - Greater than minimal pleural effusions (minimal effusions not detectable by chest
      x-ray and too small to tap safely are allowed)

      - Exudative pleural effusions, regardless of cytology

      - Malignant pleural effusion (T4 incurable disease)

   - Measurable or evaluable disease

PATIENT CHARACTERISTICS:

   - Zubrod performance status 0-1

   - Absolute neutrophil (ANC) ≥ 1,800 cells/mm³

   - Platelet count ≥ 100,000 cells/mm³

   - Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)

   - Creatinine normal OR creatinine clearance ≥ 60 mL/min

   - Bilirubin normal

   - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper
   limit of normal

   - Pulmonary Function Test (PFTs) including forced expiratory volume at 1 sec. (FEV1) ≥
   1.2 L/sec or ≥ 50% predicted (best value obtained prior to or after use of
   bronchodilator)

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective protection

   - No uncontrolled neuropathy ≥ grade 2

   - Patients with post-obstructive pneumonia allowed

   - Patients must speak English or Spanish in order to complete the mandatory EORTC QLQ-30
   and PRO-CTCAE, which are only available in certain languages

   - No prior invasive malignancy, except nonmelanoma skin cancer, carcinoma in situ of the
   breast, oral cavity, or cervix, unless the patient has been disease-free for the past
   3 years

   - No prior severe infusion reaction to a monoclonal antibody

   - No weight loss of ≥ 10% within the past 4 weeks

   - No history of allergic reaction to paclitaxel or other taxanes, or to carboplatin

   - No severe, active comorbidity, including any of the following:

      - Unstable angina and/or congestive heart failure requiring hospitalization within
      the past 6 months

      - Transmural myocardial infarction within the past 6 months

      - Acute bacterial or fungal infection requiring IV antibiotics at the time of study
      entry

      - Chronic obstructive pulmonary disease exacerbation or other respiratory illness
      requiring hospitalization or within past 30 days precluding study therapy

      - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

      - AIDS

   - No significant history of uncontrolled cardiac disease, including any of the
   following:

      - Uncontrolled hypertension

      - unstable angina

      - Myocardial infarction within the past 6 months

      - Uncontrolled congestive heart failure

      - Cardiomyopathy with decreased ejection fraction

PRIOR CONCURRENT THERAPY:

   - At least 3 weeks since prior exploratory thoracotomy (if performed)

   - Prior systemic chemotherapy allowed, provided it was not given for NSCLC

   - No prior therapy that specifically and directly targets the EGFR pathway

   - No prior radiotherapy to the region of NSCLC that would result in overlap of
   radiotherapy fields

   - No concurrent white blood cell (WBC) growth factors (i.e., filgrastim [G-CSF] or
   sargramostim [GM-CSF]) given during radiotherapy or prophylactically during
   consolidation chemotherapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting